P5622Clinical significance of late-acquired malapposition observed by serial optical coherence tomography after second-generation drug eluting stents

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Nakamura ◽  
T Yonetsu ◽  
M Nakao ◽  
S Nakagama ◽  
T Niida ◽  
...  

Abstract Background Previous studies have demonstrated that the presence of late-acquired stent malapposition after stent implantation may be a risk of late and very late stent thrombosis and myocardial infarction, which is however still controversial. Purpose We sought to investigate the incidence and prognosis of late acquired stent malapposion after second-generation drug eluting stents (2G-DES) implantation. Methods A total of 199 lesions in 139 patients who underwent optical coherence tomography (OCT) at both immediately after implantation (Baseline) and 6–12 months after 2G-DES implantation (follow-up) were investigated. We excluded lesions with stent failure before follow-up examination. We evaluated presence or absence of malapposed strut at 1mm interval of OCT images and stents with one or more cross-sections with >30% malapposed strut was defined as stents with malapposition (MP), otherwise well-apposed (WA). We divided the lesions into 4 groups according to the presence of malapposition at baseline and follow-up; WA and WA, persistent well-apposed; MP and WA, resoloved malapposition; WA and MP, late acquired malapposition (LAMP); and MP and MP, persistent malapposition. We compared the target lesion failure (TLF) rate after follow-up examination among 4 groups with Kaplan–Meier analysis. Results Median follow-up period was 469 (IQR 71–1416) days. follow-up OCT examination was performed at median 9 months (IQR 7.6–10.5). There were no significant differences in patient's and procedural characteristics among the 4 groups. TLF rate in LAMP group was 12.0% and Kaplan–Meier analysis showed no significant differences among the 4 groups in TLF rate. TLF-free suvival curves (Kaplan-Meier) Conclusion LAMP was observed by OCT at 6–12 months in 12.0% of lesions after 2G-DES implantation, which was not associated with TLF at 5 years.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Y Matsuhiro ◽  
M Nishino ◽  
H Nakamura ◽  
K Yasumoto ◽  
A Tanaka ◽  
...  

Abstract Background New generation drug eluting stents (DES) have improved target vessel failure as compared with early generation DES and bare metal stent. Contemporary several new generation DES are different each other regarding strut thickness and drug and polymer type. A little is known about which stent induces a more favorable vascular healing at follow up. Purpose In this study, we compared the vascular healing at 8-month follow up by optical coherence tomography (OCT) between 4 different kinds of new generation DES. Methods We enrolled 112 consecutive patients (121 lesions) who underwent PCI using 4 kinds of new generation DES including biodegradable-polymer everolimus-eluting stents (BP-EES), biodegradable-polymer sirolimus-eluting stents (BP-SES), durable-polymer everolimus-eluting stents (DP-EES) and durable-polymer zotarolimus-eluting stents (DP-ZES) and who underwent 8-month follow up angiogram and OCT between July 2016 and April 2018. We compared the OCT parameters including percentage of covered struts, uncovered struts, well-apposed and uncovered struts, malapposed strut and mean neointimal hyperplasia (NIH) thickness between them. Results BP-EES consisted of 29 lesions, BP-SES consisted of 25 lesions, DP-EES consisted of 38 lesions and DP-ZES consisted of 29 lesions. A total of 734 frames with 5163 struts in BP-EES, 481 frames with 4214 struts in BP-SES, 783 frames with 6119 struts in DP-EES and 583 frames with 4708 struts in DP-ZES were analyzed. As shown in a table, mean NIH thickness was significantly higher in BP-EES and BP-SES. Thus, we compared the OCT parameters between durable-polymer (DP) group including DP-ZES and DP-EES and biodegradable-polymer (BP) group including BP-EES and BP-SES. The percentage of uncovered struts was significantly lower and mean NIH thickness was significantly higher in BP group than DP group. Results of OCT parameters BP-EES (n=29) BP-SES (n=25) DP-EES (n=38) DP-ZES (n=29) P value BP group (n=54) DP group (n=67) P value Covered struts (%) 89.5±13.6 92.4±8.6 85.5±17.5 85.0±17.7 0.29 90.9±11.6 85.3±17.4 0.08 Uncovered struts (%) 8.8±10.8 7.1±8.7 14.5±17.5 15.0±17.7 0.14 8.0±9.9 14.7±17.4 0.03 Well-apposed and uncovered struts (%) 7.9±9.9 5.9±7.7 11.7±13.1 12.3±14.0 0.15 7.0±8.9 11.9±13.4 0.04 Malapposed struts (%) 0.8±1.6 1.3±2.2 2.7±5.8 2.7±4.7 0.33 1.0±1.9 2.7±5.3 0.07 Mean NIH thickness (μm) 102±57 121±48 78±28 88±33 <0.01 111±53 82±31 <0.01 Conclusion The present OCT study demonstrated that delayed neointimal healing characterized by the presence of uncovered struts and lower mean NIH thickness was less common in BP group than DP gruop. Biodegradable-polymer may be more favorable than durable-polymer from the point of view of vascular healing.


Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001394 ◽  
Author(s):  
Mohammad Riashad Monjur ◽  
Christian F Said ◽  
Paul Bamford ◽  
Michael Parkinson ◽  
Richard Szirt ◽  
...  

ObjectivesDetermine whether an ultrathin biodegradable polymer sirolimus-eluting stent (‘Orsiro’—BP-SES) has clinical benefits over second-generation durable polymer drug-eluting stents (DP-DES).MethodsWe conducted a prospective systematic review and meta-analysis of randomised clinical trials comparing Orsiro BP-SES against DP-DES (PROSPERO Registration: CRD42019147136). The primary outcome was target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR)) evaluated at the longest available follow-up.ResultsNine trials randomised 11 302 patients to either Orsiro BP-SES or DP-DES. At mean weighted follow-up of 2.8 years, the primary outcome (TLF) occurred in 501 of 6089 (8.2%) participants with BP-SES compared with 495 of 5213 (9.5%) participants with DP-DES. This equates to an absolute risk reduction of 1.3% in TLF in favour of Orsiro BP-SES (OR 0.82; 95% CI 0.69 to 0.98; p=0.03). This was driven by a reduction in TVMI (OR 0.80; 95% CI 0.65 to 0.98; p=0.03). There were no significant differences in other clinical endpoints: cardiac death, TLR and stent thrombosis.ConclusionThe Orsiro BP-SES shows promising clinical outcomes in patients undergoing percutaneous coronary intervention compared with contemporary second-generation DES at a short to medium term follow-up. More research is warranted to evaluate performance over a longer follow-up period and in different clinical and lesion subsets.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Christian Roth ◽  
Clemens Gangl ◽  
Daniel Dalos ◽  
Sabine Scherzer ◽  
Lisa Krenn ◽  
...  

Introduction: The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malapposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with different polymers designed to improve biocompatibility are unknown. Methods: Fifty patients with 59 lesions of interest were randomized to elective treatment with Everolimus-eluting stents (EES; n=17, 20 lesions)], Zotarolimus-eluting stents (ZES; n=15, 19 lesions), and Biolimus-eluting stents (BES; n=18, 20 lesions) and underwent optical coherence tomography after implantation and after one year. Results: After implantation 29 early stent malappositions (ESM) were documented in 29 lesions (49% of lesions), distributed to 11 lesions treated with EES (55%), 11 with ZES (58%), and 7 with BES (35%; n.s.). After one year 14 late stent malappositions (LSM) in 14 lesions (24%) were detected; nine ESM persisted (EPSM) after one year (1 EES, 6 ZES, 2 BES), whereas 20 ESM resolved. In addition, 9 LASM were documented (5 LASM in early well-apposed Stents, 4 LASM in Stents which also have EPSM). LASM was present in 7 hydrophilic polymer-coated ZESs (37%), in 2 fluoropolymer-coated EESs (10%), and in none of the biodegradable polymer-coated BESs (p=0.003). Independent predictors of LASM were the vessel treated (RCA as vessel with high motion; p<0.022) and type of polymer (biodegradable or permanent; p<0.035). Conclusion: The incidence of ESM and EPSM were similar, whereas the incidence of LASM was different in second-generation DES with different polymers. Biodegradable polymer prevented LASM, stent locations with significant vessel movement (RCA) enhanced LASM.


2018 ◽  
Vol 20 (8) ◽  
pp. 916-924 ◽  
Author(s):  
Yuichi Ozaki ◽  
Hector M Garcia-Garcia ◽  
Alexandre Hideo-Kajita ◽  
Kayode O Kuku ◽  
Michael Haude ◽  
...  

Abstract Aims  Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is an alternative novel device for treating coronary lesions. However, the relationship between in-scaffold dimensions after implantation of DREAMS 2G and vessel healing and luminal results at follow-up is unknown. The aim of this study is, therefore, to investigate whether the expansion index after implantation of DREAMS 2G as assessed by optical coherence tomography (OCT) impacts late luminal status and healing of the vessel wall. Methods and results  This study comprises of a total 65 out of 123 patients who were enrolled in the BIOSOLVE-II trial. We assessed both qualitative and quantitative OCT findings and the expansion index of DREAMS 2G after implantation frame by frame using OCT. Expansion index was defined as minimum scaffold area/mean reference lumen area. The over-expansion group was also defined with expansion index >1.0. The total number of analysed frames at post-procedure and 6-month follow-up was 8243 and 8263 frames, respectively. At 6-month follow-up, in-scaffold healing was documented by the reduction of 82% in dissections, 93% in attached intra-luminal mass (ILM), 65% in non-attached ILM, and 76% in jailed side branch. The over-expansion group had significantly greater in-scaffold luminal volume loss (LVL) compared with the non-over-expansion group [over-expansion: 35.0 (18.5–52.1) mm3 vs. non-over-expansion: 21.0 (11.6–37.9) mm3, P = 0.039]. Conclusion  Excellent in vivo healing process after implantation of DREAMS 2G was observed at 6 months. We found that higher expansion indices were associated with higher in-scaffold LVL at 6 months assessed by OCT.


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